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Biliary Tract NeoplasmsPhase 1/2NCT07269158

A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

A Phase 1/2 study testing Durvalumab or Pembrolizumab, Durvalumab or Pembrolizumab + Levnatinib and Durvalumab or Pembrolizumab + Venadaparib in people with Biliary Tract Neoplasms and Advanced Cancer, run by Yonsei University at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

"Biliary tract cancer (BTC) is a rare malignancy with a poor prognosis. Most patients present with unresectable disease, and even after curative-intent resection, recurrence is common. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Durvalumab or Pembrolizumab, Durvalumab or Pembrolizumab + Levnatinib and Durvalumab or Pembrolizumab + Venadaparib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSouth Korea
Study dates
Dec 2025to Sep 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Patients with advanced biliary tract cancer who have completed at least 8 cycles of Durvalumab plus Gemcitabine and Cisplatin treatment without radiologic evidence of disease progression, and are planned to receive Durvalumab maintenance therapy.
  • (Patients treated with Pembrolizumab plus Gemcitabine/Cisplatin are also eligible if they are to continue Pembrolizumab monotherapy without Gemcitabine as maintenance therapy.)
  • Patients who are 20 years of age or older at the time of signing the informed consent form.
  • Patients with histologically confirmed biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma.
  • (Patients with neuroendocrine tumors or sarcomas are excluded.)
  • Patients who are willing and able to provide written informed consent for participation in the study.
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  • Patients with measurable disease according to RECIST version 1.1.
  • ECOG performance status of 0 or 1.
  • Estimated life expectancy ≥ 3 months.
  • Patients with adequate organ and bone marrow function, without transfusion or administration of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to treatment initiation, defined as follows:
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
  • Platelet count ≥ 75 × 10⁹/L
  • Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or estimated creatinine clearance ≥ 45 mL/min (calculated using the Cockcroft-Gault formula; see Appendix 7)
  • AST and ALT ≤ 3.0 × ULN (≤ 5.0 × ULN if liver metastases are present)
  • Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome)
  • International normalized ratio (INR) ≤ 1.5 or prothrombin time ≤ 1.5 × ULN
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
  • Women of childbearing potential must agree to use highly effective contraception during the entire study period and for at least 6 months after the last dose of investigational product, and must have a negative serum pregnancy test within 14 days prior to first dose.
  • Male patients who have not undergone sterilization must agree to use highly effective contraception during the entire study period and for at least 120 days after the last dose of investigational product.
  • Patients who are willing to provide tumor tissue samples obtained by endoscopic biopsy or excisional biopsy.
  • Patients who are able to understand and comply with the study procedures and are considered likely to complete the study by the investigator.

Who cannot join

  • Patients who have received more than 10 cycles of immune checkpoint inhibitor (ICI) plus Gemcitabine and Cisplatin combination therapy for advanced biliary tract cancer.
  • Patients who have been treated for, or have evidence of recurrence or progression of, any malignancy other than biliary tract cancer within the past 3 years.
  • Exceptions: Patients who have been disease-free for ≥3 years after curative treatment, or patients with the following malignancies are not excluded: basal cell carcinoma of the skin, Stage I squamous cell carcinoma of the skin, carcinoma in situ, intramucosal carcinoma, or superficial bladder carcinoma.
  • Patients with residual adverse events from prior therapy or surgery that may interfere with the safety evaluation of the investigational product.
  • Patients with a history of hypersensitivity to any component of monoclonal antibody products.
  • Patients with a history or evidence of active, non-infectious interstitial lung disease (pneumonitis).
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  • Patients with symptomatic or clinically active brain or leptomeningeal metastases requiring treatment.
  • (Patients with asymptomatic, stable, and untreated brain metastases may be enrolled.)
  • Patients who are immunodeficient or are receiving systemic corticosteroids or other immunosuppressive therapy within 7 days prior to the first dose of the investigational product.
  • (Physiologic doses of corticosteroids, such as for acute asthma exacerbation, may be allowed after consultation with the principal investigator.)
  • Patients with uncontrolled or significant cardiovascular disease, defined as any of the following:
  • Myocardial infarction within 180 days prior to randomization
  • Uncontrolled angina within 180 days prior to randomization
  • Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV
  • Uncontrolled hypertension despite appropriate therapy (systolic ≥150 mmHg or diastolic ≥90 mmHg for >24 hours)
  • Clinically significant arrhythmia requiring treatment
  • Patients with severe chronic infections or active infections, including active or previously known tuberculosis.
  • Patients with active autoimmune disease that has required systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years.
  • (Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, is not considered systemic treatment.)
  • Patients who have received any anticancer therapy other than immune checkpoint inhibitor + Gemcitabine + Cisplatin combination therapy for biliary tract cancer.
  • (Adjuvant chemotherapy completed ≥6 months before study drug initiation is permitted.)
  • Patients who have undergone major surgery under general anesthesia within 28 days or minor/local surgery within 14 days before the start of study treatment.
  • (Diagnostic procedures such as laparoscopic biopsy may be allowed upon investigator's discretion.)
  • Patients who, in the opinion of the investigator, have any condition, treatment, active or ongoing symptomatic infection, or abnormal laboratory finding that could confound study results, interfere with study participation, or pose undue risk to the patient.
  • Patients with a known history of psychiatric disorders or substance abuse that may interfere with compliance to study requirements.
  • Patients with a known history of human immunodeficiency virus (HIV-1/2) infection.
  • Patients with active hepatitis B (HBsAg-positive and HBV DNA detected) or active hepatitis C (anti-HCV positive with detectable HCV RNA).
  • Exception: Patients with inactive or asymptomatic HBV carriers, chronic HBV infection, or non-active HCV infection are eligible if HBV DNA < 500 IU/mL (or < 2500 copies/mL) at screening.
  • Pregnant or breastfeeding women.
  • Patients who have received any unapproved or investigational drug, combination product, or formulation within 28 days prior to the start of study treatment.
  • Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea

    Seoul

Other trials in South Korea

About this study

"Biliary tract cancer (BTC) is a rare malignancy with a poor prognosis. Most patients present with unresectable disease, and even after curative-intent resection, recurrence is common. Since the ABC-02 trial, gemcitabine plus cisplatin (Gem/Cis) has been established as the standard first-line regimen, but the median overall survival (OS) remains approximately 11.7 months. Recent studies combining immune checkpoint inhibitors (ICIs) such as durvalumab or pembrolizumab with Gem/Cis have improved OS to 12.7-12.9 months, establishing ICI-based combination therapy as the new standard. However, the optimal maintenance therapy following initial chemoimmunotherapy remains undefined.

This phase IIb study enrolls patients with advanced BTC who achieved disease control after at least eight cycles of Gem/Cis plus ICI. The trial compares the efficacy and safety of ICI monotherapy maintenance versus ICI in combination with lenvatinib, venadaparib, or interleukin-2 (IL-2, SLC-3010).

Read more

Lenvatinib, through inhibition of FGFR2 and modulation of the tumor immune microenvironment, is expected to enhance ICI efficacy. PARP inhibitors may be beneficial in patients with homologous recombination deficiency (HRD) or platinum-sensitive disease. Additionally, IL-2 can activate tumor-infiltrating lymphocytes and alleviate the immunosuppressive microenvironment, potentially augmenting ICI responsiveness.

This study aims to explore a novel maintenance strategy integrating molecular targeted therapy, DNA damage repair modulation, and cytokine-based immunotherapy to overcome the limitations of current ICI monotherapy in BTC. The combination approach is expected to improve disease control and survival outcomes in patients with advanced BTC.

Read the detailed description

This phase IIb randomized trial assesses the efficacy and safety of immune checkpoint inhibitor (ICI) monotherapy versus ICI-based combination maintenance therapy with lenvatinib, venadaparib, or SLC-3010 in advanced biliary tract cancer. Durvalumab (q4w) or pembrolizumab (q3w) serve as backbone ICIs. For each group, Lenvatinib is given orally once daily, venadaparib orally, or SLC-3010 as a 60-minute IV infusion. Recommended phase II doses will be established via a 3+3 dose-escalation design, with toxicity management per NCI-CTCAE v5.0.

Being tested
Durvalumab or Pembrolizumab, Durvalumab or Pembrolizumab + Levnatinib, Durvalumab or Pembrolizumab + Venadaparib, Durvalumab or Pembrolizumab + SCL-3010
Keywords
Biliary Tract Neoplasms [including Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, and Gallbladder Neoplasms]
Medical subject headings
Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Durvalumab or PembrolizumabDrug

    Phase 2 Durvalumab 1500mg IV D1, q 4weeks or Pembrolizumab 200mg IV D1, q 3weeks

  • Durvalumab or Pembrolizumab + LevnatinibDrug

    Durvalumab 1500mg IV D1, q 4weeks or Pembrolizumab 200mg IV D1, q 3weeks Lenvatinib 12mg (≥60 kg) PO q 1cycle or 8mg (<60 kg) PO q 1cycle

  • Durvalumab or Pembrolizumab + VenadaparibDrug

    Durvalumab or Pembrolizumab + Venadaparib

  • Durvalumab or Pembrolizumab + SCL-3010Drug

    Durvalumab or Pembrolizumab + SCL-3010

Study groups in NCT07269158
Study groupRoleWhat they receive
Immunotherapy MaintenanceExperimentalDurvalumab or Pembrolizumab
Receives: Drug: Durvalumab or Pembrolizumab
Immunotherapy Maintenance + LenvatinibActive comparatorDurvalumab or Pembrolizumab + Levnatinib
Receives: Drug: Durvalumab or Pembrolizumab + Levnatinib
Immunotherapy Maintenance + VenadaparibActive comparatorDurvalumab or Pembrolizumab + Venadaparib
Receives: Drug: Durvalumab or Pembrolizumab + Venadaparib
Immunotherapy Maintenance + SCL-3010Active comparatorDurvalumab or Pembrolizumab + SCL-3010
Receives: Drug: Durvalumab or Pembrolizumab + SCL-3010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib: Recommended Phase II Dose

    Recommended Phase II Dose decided during DLT periods

    Measured: Up to 4 years

  2. Phase II: Progression Free Survival(PFS)

    Progression-free survival (PFS) is the length of time from the start of treatment until the disease progresses or the patient dies from any cause, whichever occurs first.

    Measured: Up to 4 years

Secondary outcomes (7)

  1. Objective response rate, ORR

    Objective response rate (ORR) is the proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1.

    Measured: Up to 4 years

  2. Overall Survival, OS

    Overall survival (OS) is defined as the time interval from cycle 1 day 1 to death from any cause or last follow-up.

    Measured: Up to 4 years

  3. Disease Control Rate, DCR

    Disease control rate (DCR) is the proportion of patients with CR, PR, or stable disease (SD) per RECIST 1.1.

    Measured: Up to 4 years

  4. Duration of Response, DOR

    Duration of response (DOR) is defined as the time interval from the first documented response (CR or PR) per RECIST 1.1 to tumor progression, death, or last follow-up.

    Measured: Up to 4 years

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Safety per NCI CTCAE v5.0 (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)

    Measured: Up to 4 years

  6. Quality of life (QoL) determined by EORTC QLQ-C30

    QoL determined by EORTC QLQ-C30

    Measured: Up to 4 years

  7. Quality of life (QoL)

    QoL determined by EORTC QLQ-BIL21.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07269158
Sponsor's protocol ID
4-2025-1249
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Durvalumab or Pembrolizumab, Durvalumab or Pembrolizumab + Levnatinib and Durvalumab or Pembrolizumab + Venadaparib in people with Biliary Tract Neoplasms and Advanced Cancer, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Recommended Phase II Dose (time frame: Up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07269158.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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